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Набира участници Не е приложимо NCT06568419

eBehandling - Health and Work for Patients in Specialist Mental Health Care

Не е приложима фаза (напр. обсервационно)
Заболявания: Anxiety Depression

Спонсор: Solli Distriktspsykiatriske Senter

Налично на: БГ
Обобщение
Mental health problems and disorders affect one in every five amongst the working- age adults in the countries of the Organization for Economic Cooperation and Development. This constitutes a major public health challenge that also has large implications for work participation and productivity. Major depression and anxiety are the most prevalent of the mental disorders and are therefore named common mental disorders (CMD). CMD have become a major cause of work absenteeism, with 30% of all sick leave in Norway being due to CMDs in 2024. Early interventions addressing psychological aspects and vocational challenges related to work have shown a positive effect on return to work. Therefore, finding ways to increase availability and reduce barriers to evidence-based treatments seems a viable route to reducing mental health's impact on sick leave and absenteeism. Research show that improvement in symptoms from ordinary psychotherapy has little impact on sick-leave. The same results have been found for internet-based cognitive therapy (ICBT). One of the challenges in specialised mental health care is that the work focus has been an additive or extended part of the treatment, not integrated in the treatment itself. Several studies have been conducted on psychological treatments that specifically target return to work for people with CMDs. Systematic reviews have shown that work-focused therapy has a small, but significant effect over treatment as usual on return to work and finds that 20% more workers in the intervention groups had returned to work, compared to control groups. The availability of traditional therapy is scarce and there is an need for new effective ways of delivery. internet-based cognitive therapy has been shown to be as effective as traditional therapy in many systematic reviews and meta analysis and seems a good approach to reach the goal of increasing availability. To account for the heterogene group of people on sick leave the investigators have created a transdiagnostic, work-focused internet-based cognitive behaviloural therapy program. This study aims is to is to investigate the utility and use of this treatment program for patients with common mental health disorders on sick leave or work assessment allowance. This includes the user experience of participation and experienced utility of the treatment program.
Описание
Study aims The main aim of the current study is to investigate the utility and use of a digital transdiagnostic work-focused CBT treatment program for patients with common mental health disorders on sick leave or work assessment allowance. This includes the user experience of participation and experienced utility of the treatment program. Secondary aims are related to mediators and moderators of treatment efficacy and the participants' experience with the program. Research questions 1. To what extent does the treatment program impact Return to Work, self-reported symptoms, and everyday functioning? 2. To what extent do clinical, work-related and demographic factors affect treatment adherence and treatment response? 3. To what extent do adherence and changes in work-related self-efficacy predict outcomes? 4. What type and frequency of negative effects does participants report? 5. How do participants describe their experience of use and utility of the program, as well as its challenges and benefits? Hypotheses of main effects H1a. The investigators expect a large main effect of treatment on total percentage sick leave from pre- to post treatment, with gains maintained at follow up. H1b. The investigators expect a large main effect of treatment on the number of participants with full return to work from pre- to post treatment, with gains maintained at follow up. H2. The investigators expect a large main effect of treatment on reduction on symptoms of depression and anxiety. H3. The investigators expect a positive main effect of treatment on Return to Work Self-Efficacy, from pre to post treatment, and sustained through follow up. Hypotheses of moderating and mediating effects and predictors of outcome H4. The investigators expect a negative relationship between duration of baseline work absenteeism and degree of return to work at post. Baseline work absenteeism will moderate the relationship between treatment and return to work. H5a. The investigators expect treatment credibility at baseline to be predictive of treatment adherence. H5b. The investigators expect that treatment adherence will be a mediator between treatment credibility and treatment outcome. H6. The investigators expect changes on the Return to Work Self-Efficacy Scale to predict the degree of absenteeism post treatment. H7. The investigators expect change on the Return to Work Self-Efficacy Scale to be a mediator between baseline absenteeism and return to work post-treatment. H8. The investigators expect higher depression scores (PHQ-9/CORE-OM score) to be a moderator between treatment credibility and treatment outcome and adherence. H9. The investigators expect that fewer than 10% of participants experience negative effects caused by participation, as measured by the Negative Effects Questionnaire (NEQ). Measures Demographic variables. Self-reported data will be collected on gender, age, level of education, length and degree of s
Кой може да участва
Inclusion Criteria: 1. being an outpatient in specialised mental health care service, 2. above 18 years old, 3. full or graded sick leave, or on work assessment allowance 4. primary diagnosis of F30 - F40 (ICD-10), 5. currently employed. Exclusion Criteria: 1. ongoing psychotic disorder and/or mania, 2. ongoing substance abuse, incl. sedative medications, 3. ongoing episode of major depression, 4. organic brain disease, 5. severe reading and writing difficulties.
Интервенции
Transdiagnostic, work-focused Cognitive Behavioural Therapy
BEHAVIORAL
Места на провеждане 9
Норвегия (9)
University of Bergen
Bergen , Vestland
ACTIVE_NOT_RECRUITING
Bjørgvin DPS (Helse Bergen)
Bergen , Vestland
NOT_YET_RECRUITING
Solli DPS
Bergen , Vestland
NOT_YET_RECRUITING
Sykehuset i Østfold
Fredrikstad , Østfold fylke
NOT_YET_RECRUITING
Sykehuset Innlandet
Lillehammer , Innlandet
Sykehuset Vestre Viken
Oslo , Bærum
Vinderen DPS
Oslo , Oslo
NOT_YET_RECRUITING
AHus DPS Grorudalen
Oslo , Oslo
NOT_YET_RECRUITING
Sykehuset i Vestfold
Tønsberg , Vestfold
Технически детайли
Статус
Набира участници
Фаза
Не е приложимо
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
18 Years
Максимална възраст
65 Years
Здрави доброволци
Не
Начална дата
01.12.2024
Крайна дата
01.08.2028
Регистрационен номер
NCT06568419
Източник
clinicaltrials.gov
Запитване за медицински туризъм

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